Quantum Surgical Announces Expansion of its Scientific Advisory Board

Quantum Surgical has announced the expansion of its Scientific Advisory Board (SAB) with the appointment of  Sean Tutton, MD, FSIR, FCIRSE, a board-certified diagnostic and interventional radiologist who specializes in the treatment of cancer and non-cancer related pathologic skeletal fractures at UC San Diego Health. This appointment is a key milestone for Quantum Surgical and the company’s commitment to advancing innovation in robotic-assisted procedures for interventional radiologists and expanding access to patient care.

Interventional oncology has become highly specialized and is rapidly becoming a standard of care for many multidisciplinary cancer programs. Considered the fourth pillar of oncology, the growth of this subspecialty is similar to the evolution of surgical oncology.

“Robotics has long been established in surgical fields such as general surgery, urology, and orthopedics, so its integration into interventional radiology is a natural progression,” said Dr. Sean Tutton.

“Robotic-guided procedures in interventional oncology offer significant value to physicians, but it’s the patients who really gravitate to robotics because there is the perception of the precision, efficacy, and safety,” adds Dr. Tutton.

The Epione platform is an advanced robotic-assisted technology designed for interventional radiologists performing percutaneous ablations of abdominal tumors—a minimally invasive treatment often used with curative intent. It enhances physician support by providing real-time patient monitoring, assisting in planning an optimal trajectory, improving tumor targeting precision, increasing the accuracy of therapy delivery, and offering immediate confirmation of procedural success.

“As we continue to focus on our clinical strategy of robotic-assisted procedures, we are honored with the appointment of Dr. Sean Tutton to expand our SAB of world-renowned experts in interventional oncology. His expertise and insight will support our vision of driving the demand for minimally invasive cancer care in the US market,” says Bertin Nahum, CEO and co-founder of Quantum Surgical.

“We are honored to welcome Dr. Sean Tutton to our SAB,” said Laetitia Messner, Chief Clinical Officer at Quantum Surgical. “His expertise and insights will be invaluable in shaping Quantum Surgical’s clinical strategy and driving the adoption of Epione.”

Quantum Surgical’s Scientific Advisory Board brings together a distinguished, multidisciplinary team of global experts dedicated to advancing robotic-assisted interventional oncology. The board includes:

  • Govindarajan Narayanan, MD (USA), Chief of Interventional Oncology at Miami Cardiac and Vascular Institute Miami Cancer Institute, a part of Baptist Health South Florida
  • Steven D. Colquhoun, MD (USA), Professor of Surgical Oncology, Wellstar MCG Health Medical Center (Augusta, GA)
  • Thierry De Baère, MD (France), Professor and Interventional Radiologist at Gustave Roussy Cancer Center (Villejuif)
  • Laurent Milot, MD (France), Professor and Deputy Chief Vascular & Interventional Radiology at the Hospices Civils de Lyon
  • Luigi Solbiati, MD, (Italy), Professor of Radiology at Humanitas University (Rozzano – Milan) (Honorary Member)

Source: Quantum Surgical

Novocure Announces FDA Approval for Optune Lua®

Novocure has announced that the U.S. Food and Drug Administration (FDA) has approved Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors or docetaxel, for the treatment of adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after a platinum-based regimen.

“Novocure is committed to extending survival in some of the most aggressive and difficult to treat cancers. The approval of Optune Lua brings a new and urgently needed option for people with metastatic NSCLC who have progressed while on or after platinum-based chemotherapy,” said Asaf Danziger, CEO, Novocure. “We are grateful to the patients, caregivers, investigators and healthcare providers who supported the clinical trials that led to this approval.”

Optune Lua is a portable device that produces alternating electric fields known as tumor treating fields (TTFields), which are delivered through non-invasive, wearable arrays. TTFields exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death.

“There have been a number of important advances in first-line treatment for NSCLC, but this is an aggressive disease, and most patients will develop progression, with limited effective treatment options in second line and beyond,” said Ticiana Leal, MD, Associate Professor and Director of the Thoracic Oncology Program at the Winship Cancer Institute of Emory University School of Medicine and primary investigator of the LUNAR study. “The overall survival results we observed with Optune Lua in the LUNAR study mark the first substantial improvement in more than 8 years in this patient population which, when combined with Optune Lua’s lack of systemic toxicity, make this a compelling development for many patients and their physicians who need better treatment options for this advanced disease.”

“We are excited patients with metastatic NSCLC have more options, which they urgently need,” said GO2 for Lung Cancer Chief Patient Officer Danielle Hicks. “The fight against lung cancer is always evolving, and the number of people affected by this disease is underappreciated. That is why Novocure’s commitment to advancing treatment is exciting for the whole lung cancer community.”

Data Supporting the Optune Lua Approval

The Phase 3 LUNAR study was a prospective, randomized, open-label, multicenter study that compared the use of Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel (experimental arm) to PD-1/PD-L1 inhibitors or docetaxel alone (control arm) for patients with metastatic NSCLC who progressed during or after platinum-based therapy.

The primary endpoint of the study was achieved demonstrating a statistically significant and clinically meaningful 3.3-month (P=0.04) extension in median overall survival (OS) for patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel (n=145). The group treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel had a median OS of 13.2 months (95% CI, 10.3 to 15.5 months) compared to a median OS of 9.9 months (95% CI, 8.2 to 12.2 months) in the PD-1/PD-L1 inhibitor or docetaxel treated group (n=146).

The LUNAR study included two pre-specified powered secondary endpoints. The first secondary endpoint, which met statistical significance, assessed median OS in patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor versus a PD-1/PD-L1 inhibitor alone. The second secondary endpoint, which showed a positive trend but did not meet statistical significance, assessed Optune Lua concurrently with docetaxel versus docetaxel alone.

Patients randomized to Optune Lua and a PD-1/PD-L1 inhibitor (n=70) demonstrated a median OS of 19.0 months (95% CI, 10.6 to 28.2 months) compared to a median OS of 10.8 months (95% CI, 8.3 to 17.6 months) in patients treated a with PD-1/PD-L1 inhibitor alone (n=71), which was a statistically significant extension in median OS of more than 8.0 months (P=0.02).

Patients randomized to receive Optune Lua and docetaxel (n=75) had a median OS of 11.1 months (95% CI, 8.2 to 13.9 months) compared to a median OS of 8.9 months (95% CI, 6.5 to 11.3 months) in patients treated with docetaxel alone (n=75). This 2.2 month extension in median OS did not provide a statistically significant demonstrated benefit, but did show a positive trend.

Device-related adverse events (AEs) occurred in 63.1% of patients (n=89), these were skin-related disorders under the transducer arrays. The majority of these events were low grade (Grade 1 – 2), with only 4% (n=6) experiencing Grade 3 skin toxicity that required a break from treatment. There were no Grade 4 or Grade 5 toxicities related to Optune Lua, and no device-related AEs that caused death.

Baseline patient characteristics were well balanced between cohorts: median age was 65 years (range, 22-86); 66% male, 34% female; 96% of patients had an ECOG performance status of 0-1. PD-L1 expression data were collected from 83% of patients (69 of 83 patients) enrolled at U.S. sites and were well balanced across the four cohorts.

Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the most common cause of cancer-related death worldwide 1 , and non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers. It is estimated that approximately 193,000 patients are diagnosed with NSCLC each year in the U.S.

Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease. Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease. Since 1991, radiation with a combination of platinum-based chemotherapy drugs has been the first-line standard of care for locally advanced or metastatic NSCLC. Certain immune checkpoint inhibitors, including both PD-1 and PD-L1 inhibitors, have been approved for the first-line treatment of NSCLC and the standard of care in this setting continues to evolve rapidly.

It is estimated that approximately 30,000 patients actively seek treatment for stage 4 NSCLC after progressing during or after platinum-based therapy each year in the U.S. The standard of care for second-line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first-line regimen, pemetrexed, docetaxel or immune checkpoint inhibitors.

What is Optune Lua ® approved to treat?

Optune Lua is a wearable, portable, FDA-approved device used together with PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel. It is indicated for adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after a platinum-based regimen.

Important Safety Information

Who should not use Optune Lua?

Optune Lua for mNSCLC is not for everyone. Talk to your doctor if you have:

  • An electrical implant. Use of Optune Lua together with electrical implants has not been tested and may cause the implanted device not to work properly
  • A known sensitivity to gels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes. In this case, skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and rarely may even lead to severe allergies such as a fall in blood pressure and difficulty breathing

Do not use Optune Lua if you are pregnant or are planning to become pregnant. It is not known if Optune Lua is safe or effective during pregnancy.

What should I know before using Optune Lua?

Optune Lua should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure®, the maker of Optune Lua.

  • Do not use any parts that did not come with Optune Lua Treatment Kit sent to you by Novocure or given to you by your doctor
  • Do not get the device or transducer arrays wet
  • Please be aware that Optune Lua has a cord that plugs into an electrical socket. Be careful of tripping when it’s connected
  • If you have an underlying serious skin condition where the transducer arrays are placed, discuss with your doctor whether this may prevent or temporarily interfere with Optune Lua treatment

What are the possible side effects of Optune Lua?

The most common side effects of Optune Lua when used together with certain immunotherapy and chemotherapy drugs were dermatitis, pain in the muscles, bones, or joints, fatigue, anemia, alopecia (hair loss), dyspnea, nausea, cough, diarrhea, anorexia, pruritus (itching), leukopenia, pneumonia, respiratory tract infection, localized edema (swelling), rash, pain, constipation, skin ulcers, hypokalemia (low potassium levels), hypoalbuminemia (low albumin levels), hyponatremia (low sodium levels), and dysphagia (difficulty swallowing).

Other potential adverse effects associated with the use of Optune Lua include treatment related skin irritation, allergic reaction to the adhesive or to the gel, overheating of the array leading to pain and/or local skin burns, infections at site where the arrays make contact with the skin, local warmth and tingling sensation beneath the arrays, medical device site reaction, muscle twitching, and skin breakdown/skin ulcer. Talk to your doctor if you have any of these side effects or questions.

Source: Novocure

EDAP and Avenda Health Launch World’s First AI-Assisted Focal One® Robotic HIFU Procedures

EDAP TMS SA has announced a collaboration agreement for the purpose of offering personalized prostate cancer care, utilizing Avenda’s groundbreaking AI technology, Unfold AI, to launch the world’s first AI-assisted Focal One robotic high-intensity focused ultrasound (HIFU) procedures.

Avenda Health’s Unfold AI is a multimodal AI decision support platform cleared by the U.S. Food and Drug Administration (FDA) that brings “superhuman” abilities to cancer surgeons and oncologists to power the future of cancer care. Unfold AI builds 3D patient-specific cancer maps that reveal invisible tumor extent and enables physicians to avoid leaving cancerous tissue behind while sparing healthy surrounding tissue. By leveraging Unfold AI’s planning with the Focal One robotic HIFU platform, EDAP and Avenda believe that urologists can provide a more tailored, patient-specific HIFU ablation procedure for their prostate cancer patients.

“Incorporating AI technology into the diagnostics and treatment planning for patients with prostate cancer enables urologists to more accurately pinpoint the presence of tumor cells,” said Wayne G. Brisbane, M.D., Assistant Professor of Urology at The University of California Los Angeles David Geffen School of Medicine. “Having performed the first Focal One procedures utilizing data from Unfold AI, the seamless integration of these two technologies can precisely guide the ablation for optimized oncologic control without damaging healthy surrounding structures, hence minimizing the risk of side effects.”

“We are pleased to enter into this collaboration with the Focal One team” said Shyam Natarajan, Ph.D., Chief Executive Officer of Avenda Health. “Unfold AI is a highly complementary technology that when combined with Focal One robotic HIFU, will enable urologists to map cancer effectively so that the entire tumor can be confidently eradicated. This exciting collaboration with Focal One represents a unique opportunity for Avenda to introduce our groundbreaking AI-technology to a broad community of leaders in the field of prostate cancer to further improve outcomes.”

“We are excited to announce this unique and important collaboration with the highly talented team at Avenda Health during Prostate Cancer Awareness Month and congratulate Dr. Brisbane on successfully completing the first Unfold-AI assisted Focal One procedures,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “The combination of Avenda’s Unfold AI patient-specific cancer map with Focal One’s proprietary HIFUsion® software significantly augments a surgeon’s ability to combine existing diagnostic information and deep-learning algorithms to assist the urologist in creating a personalized precise treatment plan. AI-assisted procedures therefore represent an important and strategic next step in the evolution of the Focal One platform that will help us remain at the forefront of delivering the most advanced treatment solutions for patients with prostate cancer.”

The Paoli-Calmettes Institute Adopts Quantum Surgical’s Epione® Robot

Quantum Surgical has announced that the Paoli-Calmettes Institute (IPC) has acquired Epione®, Quantum Surgical’ robotic platform which enables curative and early treatment of tumors. The first patient was treated yesterday in Marseille. The IPC is the 4th center in the world to offer its patients this minimally invasive treatment in which one or several needles are inserted through the skin into the tumor to destroy it.

Epione® is a technology combining robotics and AI that enables interventional radiologists to perform safe and effective percutaneous tumor ablations, a minimally invasive treatment where one or more needles are inserted through the skin to destroy the tumor. This platform is designed to plan, target, execute, and confirm the ablation of abdominal and pulmonary tumors, with other locations currently under study.

After Baptist Health Hospital in Miami, Gustave Roussy Institute in Villejuif, and Hospices Civils de Lyon, the Paoli-Calmettes Institute is the fourth center in the world to acquire the Epione® robot.

For over 10 years, at IPC, patients have been benefiting from these percutaneous ablation techniques to treat small tumors, either using heat (radiofrequency, microwave) or cold (cryotherapy). These treatments are performed within a dedicated unit consisting of three operating rooms with two interventional scanners and an angiography table. The advent of robotics in interventional radiology will further enhance the safety and precision of these procedures.

Professor Norbert Vey, General Director of IPC, explains: “IPC is a cancer center dedicated to offering increasingly effective treatments to its patients. IPC’s strategy now includes developing minimally invasive interventions to enhance patients’ quality of life and reduce after-effects. By offering minimally invasive tumor ablations, IPC will be able to treat more patients and improve their comfort.”

Quantum Surgical and the Paoli-Calmettes Institute have signed a scientific and clinical partnership agreement focusing on clinical studies, with Quantum Surgical acting as the promoter, as well as pioneering topics in robotics.

“Epione® is a unique robotic solution that enables the treatment of tumors in hard-to-reach areas, where only a few experts can intervene. With the robot, these minimally invasive treatments will be standardized, allowing us to provide this curative treatment to a larger number of patients,” adds Dr. Gilles Piana, Head of the Medical Imaging Department at IPC.

“This new acquisition by the Paoli-Calmettes Institute in Marseille marks a significant milestone for Quantum Surgical and is a recognition of the benefits of Epione®. We are delighted that an increasing number of patients can benefit from our minimally invasive technology, which destroys tumors while improving their comfort,” states Bertin Nahum, President and Co-founder of Quantum Surgical.

Source: Quantum Surgical

Siemens Healthineers Launches Cinematic Reality App for Apple Vision Pro

Siemens Healthineers has announced the launch of an app designed for Apple Vision Pro that enables users such as surgeons, medical students, or patients to view immersive, interactive holograms of the human body captured through medical scans in their real-world environment. Visualizing the renderings through the app could assist in surgical planning and medical education, or help patients visualize procedures. The Cinematic Reality app 1* is now available on the Apple App Store. Furthermore, visitors to the HIMSS trade show in Orlando, Florida, will have the chance to experience it in person at the Siemens Healthineers booth from March 12 to 14. 

“Cinematic Reality gives people the opportunity to immerse themselves in a world of photorealistic renderings of the human anatomy. Apple Vision Pro perfectly presents that three-dimensional experience, combined with great flexibility and standalone use. We see great potential for the technology for clinical as well as educational purposes,” said Christian Zapf, head of Digital and Automation at Siemens Healthineers. 

Apple Vision Pro, the company’s first spatial computer, seamlessly blends digital content with the user’s physical world. Intuitive gestures allow users to interact with apps by simply looking at them, tapping their fingers to select, flicking their wrist to scroll, or using a virtual keyboard or dictation to type. Using the Cinematic Reality app on Apple Vision Pro allows users to zoom into details of clinical images, enlarging content and rotating around a rendering of the human body and provides basic two-dimensional reading tools such as scrolling. Cinematic Reality app users can simply visualize clinical cases directly through the native app without the need to connect to an additional computer. 

The Cinematic Reality app is designed to take advantage of the power of Apple Silicon and Metal, laying a strong foundation for future development. The app helps to provide a more realistic way of visualizing organs or body parts, making it possible to better explain clinical cases to patients, discuss clinical questions around referrals, or to educate medical students. In the future, this could assist surgeons in pre-operative planning, facilitate interdisciplinary communication between specialists in different fields, or help non-radiologists and patients to better understand scans and conditions. 

“We have further optimized our existing algorithm of Cinematic Reality to allow computationally intense methods to run on Apple Vision Pro’s M2 processor”, said Sebastian Krueger, lead developer Cinematic Reality at Siemens Healthineers. “The rendering technique is used to simulate the way light interacts with objects in a virtual environment, producing highly realistic lighting and reflections in the resulting images.”

1* Cinematic Reality for Apple Vision Pro is a prototype. It is under development and not commercially available. Its future availability cannot be guaranteed.

Source: Siemens Healthineers

EDAP Announces FDA Breakthrough Device Designation for Focal One®

EDAP TMS SA has announced that its Focal One platform has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA) for the treatment of deep infiltrating endometriosis (DIE). In June 2018, the FDA cleared Focal One Robotic Focal HIFU for the ablation of prostatic tissue.

“Receiving Breakthrough Device designation from the FDA represents a major milestone and reinforces our commitment to expand the use of Focal One Robotic HIFU technology to treat other patient conditions beyond prostate disease,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “This designation reflects the FDA’s recognition that deep infiltrating endometriosis remains a significant unmet medical need in women’s health with few treatment alternatives. By expanding our proprietary robotic HIFU technology, we aim to provide women with a safe and effective treatment option that is significantly less invasive and less morbid than conventional surgical approaches.”

By definition, the FDA’s Breakthrough Device designation is granted to products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This unique program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review. The Focal One system being granted a Breakthrough Device designation underscores the significance of this innovative development for DIE patients.

Rectal endometriosis induces lesions associated with painful symptoms that can seriously alter quality of life for many women. Focal One HIFU is a non-invasive, robotic ablative procedure using a high-intensity ultrasound probe to deliver tissue devitalization through use of acoustic cavitation and thermal ablation.

In January 2022, EDAP reported positive results from the Phase 2 Endo-HIFU-1R study (N=60) evaluating Focal One HIFU for the treatment of deep infiltrating rectal endometriosis, and this data was included in EDAP’s submission in consideration for receiving Breakthrough Device designation from the FDA. The study evaluated the effect of HIFU treatment on endometriosis symptoms and Quality of Life (QoL). Results showed a significant decrease of the evaluated symptoms (acute pelvic pain, dyspareunia, diarrhea, constipation, rectal bleeding, false urges, tenesmus, rectal spams, posterior pelvic pain and asthenia) from the first post-treatment evaluation (at one month), and the reduction of symptoms was maintained at three and six months following HIFU treatment. With respect to QoL measurement, a significant improvement was also observed from the first month after HIFU treatment and maintained at three and six months after treatment for almost all evaluated criteria: physical functioning, role limitation due to emotional problems, energy – fatigue, emotional well-being, social functioning, bodily pain, general health, and on physical and mental global score components. The study also blindly evaluated the evolution of nodule volume via MRI, noting a significant reduction of the volume of lesions observed at six months. Results from the study also showed a positive safety profile with 96.7% of patients with no or non-significant adverse events (Clavien 1), 3.3% of treated patients presenting Clavien 2 complications and zero patients presenting Clavien 3 complications.

In February 2024, EDAP announced the completion of enrollment in a Phase 3 study evaluating Focal One HIFU therapy for the treatment of deep infiltrating rectal endometriosis. The ongoing Phase 3 study (NCT05755958) is a comparative, randomized, double blind trial, with the primary objective of evaluating acute pelvic pain levels in 60 patients. Patients enrolled in the study are being followed for three months comparing HIFU treatment to a sham group. The last patient was treated in January 2024. Study results are expected in the second half of 2024.

About Endometriosis
Endometriosis is a chronic, progressive disease affecting nearly 10-12% of women of reproductive age. The disease is characterized by tissue resembling the lining of the uterus growing outside the uterine cavity. This extraneous endometrial tissue may commonly occur in the peritoneum or in pelvic and extra-pelvic organs such as the bowels, appendix, bladder, diaphragm muscle and thoracic cavity. The space between the uterus and the rectum, known as the Douglas pouch, is one of the most frequent and symptomatic sites of endometriosis leading to rectal endometriosis.1

1 Source: https://drseckin.com/rectal-endometriosis/

Source: EDAP TMS

Canon Medical Announces Second Installation of its Canon Photon-counting CT (PCCT) System at Radboud University Medical Center

Canon Medical Systems Corporation has completed the second installation of its Canon photon-counting CT (PCCT) system worldwide at Radboud University Medical Center (Chair: Dr. Bertine Lahuis; location: Nijmegen, the Netherlands), and clinical research began in late January. PCCT is expected to be the next generation of X-ray CT.

Radboud University Medical Center is an academic medical center specializing in patient care, scientific research, teaching, and training. The center offers innovative medical care that is shaping the future of healthcare, focusing on its mission to make a significant impact on health care. The Department of Radiology at Radboud University Medical Center leads one of the best research groups in Europe, working with more than 150 researchers on advanced studies to provide patient care and improve health care.
Canon Medical entered into an agreement on joint clinical research with Radboud University Medical Center on November 14, 2023,*1 and clinical research aimed at early practical application of PCCT was started, led by Prof. Mathias Prokop, Chairman of the Department of Radiology at Radboud University Medical Center. The purpose of this research is to explore the clinical usefulness and potential of PCCT, such as ultra-low dose imaging and quantitative evaluation of contrast media, using image data acquired by PCCT.
Prof. Prokop commented, “The first clinical exams on our photon counting CT scanner were made in January and confirmed its improved spatial resolution. As a chest radiologist, I’m excited to see that our diagnostic abilities may be pushed past their current limits. Together with Canon, we plan to further explore the scanner’s spectral imaging*2 features. By combining it with existing techniques like subtraction or perfusion imaging we’d like to venture into functional imaging as well.”

PCCT is a diagnostic imaging system equipped with a next-generation detector (photon-counting detector)*3 that, compared to conventional X-ray CT systems, allows multiple energy collection. PCCT can identify multiple material compositions and is expected to improve diagnostic accuracy by providing images with superior quantitativity. In addition, with the higher resolution of PCCT, the detectability of lesions should be improved at even lower exposure doses than with conventional systems. Based on these advanced system capabilities, PCCT is expected to become a next-generation CT imaging technique with the capability to provide outstanding clinical value, and its clinical introduction is awaited at healthcare institutions around the world.
We will accelerate the development of PCCT by ensuring that the most suitable product is developed based on direct input from clinical practice. Through the early implementation of Canon PCCT, which brings together various technologies that Canon has cultivated over the years, Canon Medical will contribute to the further development of diagnostic imaging technology and the improvement of healthcare.　With Canon’s innovations and technology leadership, Canon Medical will aim for the No. 1 share in the global CT market.

A variety of our healthcare solutions will be exhibited at ECR 2024 (European Congress of Radiology) to be held in Vienna from February 28 to March 3, and a seminar by Radboud University based on the firsthand experience of using PCCT is scheduled on March 1.

*1: Canon Medical Systems Accelerates Global Clinical Research to Realize Next-Generation Photon-Counting CT
*2: A function of PCCT which allows images to be obtained based on X-rays with different energy levels. It is expected to enable the provision of diagnostic information, such as differentiation of materials and quantitative assessment, that exceeds what can be achieved with conventional CT.
*3: Photon Counting CT | CT | Canon Medical Systems

Source: Canon Medical

EDAP Completes Enrolment in Phase 3 Study Evaluating Focal One HIFU Therapy for the Treatment of Rectal Endometriosis

EDAP TMS has announced that it has completed enrollment in its Phase 3 study (Endo-HIFU-R2) evaluating Focal One High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating rectal endometriosis. The ongoing Phase 3 study (NCT05755958) is a comparative, randomized, double blind trial, with the primary objective of evaluating acute pelvic pain levels in 60 patients. Select treated patients are followed three months post-HIFU treatment in comparison to a sham group. The last patient was treated in January. Study results are expected in the second half of 2024.

“We are pleased to announce the completion of enrollment in our Phase 3 study, which represents a significant clinical milestone for our company,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “Considering the fact that the Phase 3 study included a sham-controlled arm, we are highly encouraged by the robust pace of enrollment which we believe speaks to the strong interest from patients and physicians in exploring alternative treatment modalities beyond surgery. Rectal endometriosis is a painful and debilitating condition that impacts thousands of women each year with surgical intervention being the primary option beside medical treatment. By utilizing robotic HIFU, we hope to address this significant unmet need in women’s health by developing a safe and effective treatment option that is significantly less invasive than conventional surgical approaches. We would like to thank the patients and clinical investigators who participated in this study, and we look forward to reporting results from the study later this year.”   

Rectal endometriosis induces lesions associated with painful symptoms that can seriously alter quality of life for many women. Focal One HIFU is a non-invasive ablative procedure using a high-intensity ultrasound probe to deliver tissue devitalization through use of acoustic cavitation and thermal ablation.

In January 2022, EDAP reported positive results from the Phase 2 Endo-HIFU-1R study (N=60) evaluating Focal One HIFU for the treatment of deep infiltrating rectal endometriosis. Results from the study showed a positive safety profile with 96.7% of patients with no or non-significant adverse events (Clavien 1), 3.3% of treated patients presenting Clavien 2 complications and zero patients presenting Clavien 3 complications. The study also evaluated the effect of HIFU treatment on endometriosis symptoms and Quality of Life (QoL). Results showed a significant decrease of the evaluated symptoms (acute pelvic pain, dyspareunia, diarrhea, constipation, rectal bleeding, false urges, tenesmus, rectal spams, posterior pelvic pain and asthenia) from the first post-treatment evaluation (at one month), and the reduction of symptoms was maintained at three and six months following HIFU treatment. With respect to QoL measurement, a significant improvement was also observed from the first month after HIFU treatment and maintained at three and six months after treatment for almost all evaluated criteria: physical functioning, role limitation due to emotional problems, energy – fatigue, emotional well-being, social functioning, bodily pain, general health, and on physical and mental global score components. The study also blindly evaluated the evolution of nodule volume via MRI, noting a significant reduction of the volume of lesions observed at six months.

Source: EDAP

Quantum Surgical Receives NMPA Market Authorization for its Epione® Robot

Quantum Surgical receives market authorization from the National Medical Products Administration (NMPA) for the use and commercialization of its Epione® robot in China. Epione enables early and minimally invasive treatment of abdominal tumors. Nearly 610,000 new cases are diagnosed in China each year [1].

Quantum Surgical’s flagship product, the Epione® robotic platform, is dedicated to the curative treatment of cancers. Epione® allows physicians to treat inoperable tumors that are particularly difficult to reach, due to their size or their location, at an early stage, in a simple and effective way.

Epione® can be used to treat abdominal tumors (including the liver, kidneys, and pancreas) and over 200 patients have already been treated in France and the United States.

The NMPA market authorization allows for offering this innovative, better targeted, and minimally invasive treatment to new patients in China, where nearly 610,000 new cases of abdominal cancers are diagnosed each year.

“Thanks to the NMPA market authorization, we are very excited to be able to offer our Epione® solution to interventional oncologists in China. This is an important step that will provide Chinese patients with an innovative and minimally invasive treatment to treat their abdominal tumors at an early stage, while improving their comfort” says Bertin Nahum, President and Co-founder of Quantum Surgical.

“The NMPA market authorization confirms the effectiveness of Epione® and, above all, the relevance of its deployment in China, where nearly 610,000 cases of abdominal cancers are diagnosed each year” explains Laetitia Messner, Clinical Director of Quantum Surgical.

Epione® is a robotic-assisted percutaneous ablation system, using a robotic arm, a navigation system and a camera.

This procedure is an alternative to surgery in which a needle is inserted through the skin to the tumor to destroy it. This technique makes it possible to treat tumors that are particularly difficult to reach, due to their size or their location.

Relying on the know-how of the practitioner, Epione® integrates all the steps of a percutaneous ablation procedure in a single platform: planning, targeting, ablation, confirmation.

[1] Globocan, 2020

Source: Quantum Surgical